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Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3021538Model R1: 5x50mL, R2: 1x5mL，Calibration sample: 2mLRef 3016557Ref 3023203Ref 3000479Model R1: 4x50mL, R2: 1x5mL, Calibration sample: 2mLRef 3021191
Identity
- Trade Name
- TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT METHOD) EUDAMED
- Device Name
- TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT METHOD) EUDAMED
- Model / Reference
- R1: 5x50mL, R2: 1x5mL，Calibration sample: 2mL EUDAMED3021538 EUDAMED3016557 EUDAMED3023203 EUDAMEDR1: 4x50mL, R2: 1x5mL, Calibration sample: 2mL EUDAMED3000479 EUDAMED3021191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794593856 EUDAMED06942202259197 EUDAMED06942202213533 EUDAMED06942202259180 EUDAMED06942202259210 EUDAMED
- Basic UDI-DI
- B-06925794593856 EUDAMEDB-06942202259197 EUDAMEDB-06942202213533 EUDAMEDB-06942202259180 EUDAMEDB-06942202259210 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06925794593856 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 10bbbe07-f29c-405e-83f5-dbaacd8ec32a 61 fields · synced Sep 17, 2026
- EUDAMED b11fe1bc-13af-4a97-8d1c-31e9dc1aa97f 61 fields · synced May 16, 2026
- EUDAMED 2931c2f9-71af-4087-aab6-df429607d996 61 fields · synced May 17, 2026
- EUDAMED e8ec7aab-c86f-47cf-96a6-f3a446b3b292 61 fields · synced May 17, 2026
- EUDAMED 7527fc2f-7e37-4ec4-982f-0f7de786fb24 61 fields · synced May 18, 2026